Evaluation of a Simplified Protocol for Regional Citrate Anticoagulation in Continuous Venovenous Hemodiafiltration

NCT00583765 | Completed DMC

• 1 other identifier: 5793
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Dialysis requires thinning of the blood to prevent clotting in the dialysis machine. Thinning of the blood is necessary but some forms of blood thinners may cause bleeding. Therefore, researchers are seeking ways to minimize bleeding risks and ensure effective dialysis. One medication used to thin the blood in the dialysis machine is citrate. Citrate has the advantage of having its blood-thinning properties quickly reversed by calcium in the patient's blood. As a consequence, only the blood in the machine is thinned, greatly reducing the risk of bleeding when dialysis is carried out using other blood thinners. Until now, most patients who received citrate for dialysis were administered the citrate in a separate infusion through an IV pump into the dialysis machine. This method requires complex monitoring and calculations. This study is about Prismocitrate which is a dialysis fluid very similar to the regular dialysis fluid that is used in this intensive care unit, except that this fluid already contains exactly the correct amount of citrate. Thus, this method does not require a separate pump for citrate and calculations to pump the citrate into the blood as it goes through the kidney machine. Having the citrate already contained in the dialysis fluid simplifies the procedure and reduces the possibility of calculation errors. This study seeks to determine if this simplified means of providing blood thinning in the kidney machine also results in the correct balance of blood salts.

Conditions

Kidney Failure, Acute

Keywords

Kidney Failure, Acute; Hemodialysis; Hemofiltration; Anticoagulation; Citrate

Outcome Measures

Primary Outcomes (1)

• metabolic stability

  24, 48 and 72 hours

Secondary Outcomes (1)

• Hemofilter survival

  24, 48 and 72 hours

Study Arms (1)

A

Critically ill patients with acute renal failure requiring continuous renal replacement therapy

Drug: Regional citrate anticoagulation

Interventions

Regional citrate anticoagulation DRUG

Continuous venovenous hemodiafiltration with regional anticoagulation using dilute trisodium citrate. This requires the use of a continuous renal replacement therapy (CRRT) machine in venovenous hemodiafiltration mode. Anticoagulation and buffer are provided by the use of a dilute solution of trisodium citrate in the replacement fluid which is infused in a predilution mode. Standard bicarbonate containing dialysate is used.

Also known as: Prismocitrate - the study fluid, Prismocal - the commercially available dialysate

A

Eligibility Criteria

• Age: 17 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Male or female between 17 and 80 years of age. 2. Critically ill intensive care unit patient. 3. Renal failure requiring continuous venovenous hemodiafiltration. 4. Likely to survive for at least 72 hours

You may qualify if:

• Male or female between 17 and 80 years of age.
• Intensive care unit patient.
• Acute renal failure requiring continuous venovenous hemodiafiltration.
• Likely to survive for at least 72 hours

You may not qualify if:

• Age \> 80 years
• Need for systemic anticoagulation, fibrinolytic therapy or activated protein C
• Acute or chronic hepatic failure

Sponsors & Collaborators

• University of Alberta: lead
• Gambro Renal Products, Inc.: collaborator

Study Sites (1)

General Systems Intensive Care Unit, University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (26)

• Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (BEST Kidney) Investigators. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005 Aug 17;294(7):813-8. doi: 10.1001/jama.294.7.813.

  PMID: 16106006 BACKGROUND

• Tolwani AJ, Campbell RC, Schenk MB, Allon M, Warnock DG. Simplified citrate anticoagulation for continuous renal replacement therapy. Kidney Int. 2001 Jul;60(1):370-4. doi: 10.1046/j.1523-1755.2001.00809.x.

  PMID: 11422774 BACKGROUND

• Uchino S, Bellomo R, Kellum JA, Morimatsu H, Morgera S, Schetz MR, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-Van Straaten HM, Ronco C; Beginning and Ending Supportive Therapy for the Kidney (B.E.S.T. Kidney) Investigators Writing Committee. Patient and kidney survival by dialysis modality in critically ill patients with acute kidney injury. Int J Artif Organs. 2007 Apr;30(4):281-92. doi: 10.1177/039139880703000402.

  PMID: 17520564 BACKGROUND

• Tolwani AJ, Prendergast MB, Speer RR, Stofan BS, Wille KM. A practical citrate anticoagulation continuous venovenous hemodiafiltration protocol for metabolic control and high solute clearance. Clin J Am Soc Nephrol. 2006 Jan;1(1):79-87. doi: 10.2215/CJN.00040505. Epub 2005 Nov 23.

  PMID: 17699194 BACKGROUND

• Kutsogiannis DJ, Gibney RT, Stollery D, Gao J. Regional citrate versus systemic heparin anticoagulation for continuous renal replacement in critically ill patients. Kidney Int. 2005 Jun;67(6):2361-7. doi: 10.1111/j.1523-1755.2005.00342.x.

  PMID: 15882280 BACKGROUND

• Kutsogiannis DJ, Mayers I, Chin WD, Gibney RT. Regional citrate anticoagulation in continuous venovenous hemodiafiltration. Am J Kidney Dis. 2000 May;35(5):802-11. doi: 10.1016/s0272-6386(00)70248-4.

  PMID: 10793012 BACKGROUND

• Jacka MJ, Ivancinova X, Gibney RT. Continuous renal replacement therapy improves renal recovery from acute renal failure. Can J Anaesth. 2005 Mar;52(3):327-32. doi: 10.1007/BF03016071.

  PMID: 15753507 BACKGROUND

• Gibney RT, Kimmel PL, Lazarus M. The Acute Dialysis Quality Initiative--part I: definitions and reporting of CRRT techniques. Adv Ren Replace Ther. 2002 Oct;9(4):252-4. doi: 10.1053/jarr.2002.35571.

  PMID: 12382226 BACKGROUND

• Gibney RT, Stollery DE, Lefebvre RE, Sharun CJ, Chan P. Continuous arteriovenous hemodialysis: an alternative therapy for acute renal failure associated with critical illness. CMAJ. 1988 Nov 1;139(9):861-6.

  PMID: 3179891 BACKGROUND

• Morath C, Miftari N, Dikow R, Hainer C, Zeier M, Morgera S, Weigand MA, Schwenger V. Sodium citrate anticoagulation during sustained low efficiency dialysis (SLED) in patients with acute renal failure and severely impaired liver function. Nephrol Dial Transplant. 2008 Jan;23(1):421-2. doi: 10.1093/ndt/gfm629. Epub 2007 Oct 3. No abstract available.

  PMID: 17913732 BACKGROUND

• Fischer KG. Essentials of anticoagulation in hemodialysis. Hemodial Int. 2007 Apr;11(2):178-89. doi: 10.1111/j.1542-4758.2007.00166.x.

  PMID: 17403168 BACKGROUND

• Amanzadeh J, Reilly RF Jr. Anticoagulation and continuous renal replacement therapy. Semin Dial. 2006 Jul-Aug;19(4):311-6. doi: 10.1111/j.1525-139X.2006.00178.x.

  PMID: 16893409 BACKGROUND

• Mariano F, Tetta C, Ronco C, Triolo G. Is there a real alternative anticoagulant to heparin in continuous treatments? Expert Rev Med Devices. 2006 Jan;3(1):5-8. doi: 10.1586/17434440.3.1.5. No abstract available.

  PMID: 16359246 BACKGROUND

• Gritters M, Grooteman MP, Schoorl M, Schoorl M, Bartels PC, Scheffer PG, Teerlink T, Schalkwijk CG, Spreeuwenberg M, Nube MJ. Citrate anticoagulation abolishes degranulation of polymorphonuclear cells and platelets and reduces oxidative stress during haemodialysis. Nephrol Dial Transplant. 2006 Jan;21(1):153-9. doi: 10.1093/ndt/gfi069. Epub 2005 Sep 6.

  PMID: 16144857 BACKGROUND

• Gabutti L, Ferrari N, Mombelli G, Keller F, Marone C. The favorable effect of regional citrate anticoagulation on interleukin-1beta release is dissociated from both coagulation and complement activation. J Nephrol. 2004 Nov-Dec;17(6):819-25.

  PMID: 15593057 BACKGROUND

• Morgera S, Scholle C, Voss G, Haase M, Vargas-Hein O, Krausch D, Melzer C, Rosseau S, Zuckermann-Becker H, Neumayer HH. Metabolic complications during regional citrate anticoagulation in continuous venovenous hemodialysis: single-center experience. Nephron Clin Pract. 2004;97(4):c131-6. doi: 10.1159/000079171.

  PMID: 15331942 BACKGROUND

• Mariano F, Tetta C, Stella M, Biolino P, Miletto A, Triolo G. Regional citrate anticoagulation in critically ill patients treated with plasma filtration and adsorption. Blood Purif. 2004;22(3):313-9. doi: 10.1159/000078788.

  PMID: 15256798 BACKGROUND

• Swartz R, Pasko D, O'Toole J, Starmann B. Improving the delivery of continuous renal replacement therapy using regional citrate anticoagulation. Clin Nephrol. 2004 Feb;61(2):134-43. doi: 10.5414/cnp61134.

  PMID: 14989634 BACKGROUND

• Bunchman TE, Maxvold NJ, Brophy PD. Pediatric convective hemofiltration: Normocarb replacement fluid and citrate anticoagulation. Am J Kidney Dis. 2003 Dec;42(6):1248-52. doi: 10.1053/j.ajkd.2003.08.026.

  PMID: 14655197 BACKGROUND

• Tobe SW, Aujla P, Walele AA, Oliver MJ, Naimark DM, Perkins NJ, Beardsall M. A novel regional citrate anticoagulation protocol for CRRT using only commercially available solutions. J Crit Care. 2003 Jun;18(2):121-9. doi: 10.1053/jcrc.2003.50006.

  PMID: 12800123 BACKGROUND

• Gabutti L, Marone C, Colucci G, Duchini F, Schonholzer C. Citrate anticoagulation in continuous venovenous hemodiafiltration: a metabolic challenge. Intensive Care Med. 2002 Oct;28(10):1419-25. doi: 10.1007/s00134-002-1443-y. Epub 2002 Sep 6.

  PMID: 12373466 BACKGROUND

• Bunchman TE, Maxvold NJ, Barnett J, Hutchings A, Benfield MR. Pediatric hemofiltration: Normocarb dialysate solution with citrate anticoagulation. Pediatr Nephrol. 2002 Mar;17(3):150-4. doi: 10.1007/s00467-001-0791-0.

  PMID: 11956849 BACKGROUND

• Palsson R, Laliberte KA, Niles JL. Choice of replacement solution and anticoagulant in continuous venovenous hemofiltration. Clin Nephrol. 2006 Jan;65(1):34-42. doi: 10.5414/cnp65034.

  PMID: 16429840 BACKGROUND

• Palsson R, Niles JL. Regional citrate anticoagulation in continuous venovenous hemofiltration in critically ill patients with a high risk of bleeding. Kidney Int. 1999 May;55(5):1991-7. doi: 10.1046/j.1523-1755.1999.00444.x.

  PMID: 10231464 BACKGROUND

• Ward DM. The approach to anticoagulation in patients treated with extracorporeal therapy in the intensive care unit. Adv Ren Replace Ther. 1997 Apr;4(2):160-73. doi: 10.1016/s1073-4449(97)70043-8.

  PMID: 9113232 BACKGROUND

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  PMID: 8320930 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Noel Gibney, MB BCh BAO

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: April 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 4, 2008

Record last verified: 2008-06

Locations

CA (1)